*Please note that we publish this newsletter only when Congress is in session.

Congress

Legislation and Committee Activity

House Passes First Package of Appropriations Bills – The House approved a package today – commonly called a “mini-bus” – of three fiscal year 2019 Appropriations bills, including Energy and Water, Military Construction and Veterans Affairs, and the Legislative Branch. Read More

Roll Call: Congress’ Focus on Opioids Misses Larger Crisis– Congress faced a startling public health and political problem throughout 2016 as the number of people dying from opioid addiction climbed. The number of Americans succumbing to drug overdoses more than tripled between 1999 and 2015, affecting a whiter and more geographically diverse population than previous drug crises. Lawmakers ultimately approved some modest policies aimed at curbing prescription drug abuse and provided $1 billion to support state efforts. Read More

Politico: Bill Cassidy Doesn’t Want to be ‘Don Quixote’ on ACA Repeal – Sen. Bill Cassidy (R-LA), co-author of a high-profile Obamacare repeal bill, isn’t so sure Congress should take another crack at undoing the law this year. However, he said lawmakers should move on legislation to make health care more affordable. Read More Read More

Hearing on Lowering Costs and Expanding Access to Health care through Consumer – Directed Health Plans– On Wednesday, the House Ways and Means Committee held a hearing on lowering costs and expanding access to health care through consumer-directed health plans. Read More Read More

Bipartisan E&C, Senate HELP Leaders Press HHS for Answers on Health Care Cybersecurity Efforts – On Tuesday, bipartisan and bicameral health care leaders sent a letter to HHS raising concerns about the department’s implementation of a portion of the Cybersecurity Information Sharing Act (CISA) of 2015. The leaders requested information regarding the “Cyber Threat Preparedness Report” (CTPR), as well as other important status updates. Read More

HHS Secretary Azar Testifies Before Education and Workforce Committee– On Wednesday, the Committee on Education and the Workforce, chaired by Rep. Virginia Foxx (R-NC), held an oversight hearing with Department of Health and Human Services (HHS) Secretary Alex Azar to review the Department’s policies and priorities. Read More

Alexander, Bennet Introduce “PREEMIE” Bill to Give Infants Hope for Healthier Lives– On Thursday, Sens. Lamar Alexander (R-TN) and Michael Bennet (D-CO) introduced the PREEMIE Act (S. 3029) to revise and extend the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act. Reps. Anna Eshoo (D-CA) and Leonard Lance (R-NJ) are expected to introduce companion legislation in the House of Representatives. Read More

Politico: McConnell Cancels Most of August Recess– Sen. Majority Leader Mitch McConnell (R-KY) is canceling all but a week of the Senate’s traditional August recess, hoping to keep vulnerable Democrats off the campaign trail and confirm as many of President Donald Trump’s judicial and executive branch nominees as possible. Read More

Administration

Statement from the Press Secretary Regarding the Youth Opioid Prevention Ad Campaign– Today, the Administration unveiled the first set of public awareness ads to combat the opioid crisis. The first set of ads is focused on preventing young adults, ages 18-24, from misusing or abusing opioids. Read More

Chairman Pai Proposes Funding Increase for Rural Health Care Program – Federal Communications Commission Chairman Ajit Pai announced that he has circulated a draft order to his colleagues that would take immediate action to significantly increase funding for the Universal Service Fund’s Rural

Politico: Trump Seeks to Reorganize the Federal Government – The Trump administration is preparing to release a sweeping plan for reorganizing the federal government that includes a major consolidation of welfare programs — and a renaming of the Health and Human Services Department. Read More

Readout of HHS Secretary Azar’s Roundtable with Medical Device Leaders– On Thursday, HHS Secretary Alex Azar held a roundtable discussion with leaders from medical device companies and the industry group AdvaMed. The gathering was part of ongoing efforts at HHS to explore ways to break down barriers to innovation as part of the Trump Administration’s work to improve health care in the United States. Read More

Health Care Informatics: The Push Towards Value – Based Care is Forcing the HIT Vendor Market Forward– The health care policy and payment landscape is rapidly evolving, with the move to value-based care models a driving force behind current health care reform efforts. Case in point: in a recent speech at the World Health Care Congress, Health and Human Services (HHS) Secretary Alex Azar laid out his agency’s overall policy strategy and cited accelerating the value-based transformation of the Health care system as a top priority. Read More

NIH releases strategic plan for data science– Storing, managing, standardizing and publishing the vast amounts of data produced by biomedical research is a critical mission for the National Institutes of Health. In support of this effort, NIH today released its first Strategic Plan for Data Science that provides a roadmap for modernizing the NIH-funded biomedical data science ecosystem. Read More

CMS

The Hill: Watchdog Report Finds surge in Medicare Drug Spending – Medicare spending on prescription drugs has surged in recent years, despite a drop in the number of prescriptions, according to a new report. The report from the Department of Health and Human Services (HHS) inspector general finds that Medicare Part D spending for brand-name drugs rose by 62 percent from 2011 to 2015, from $49 billion to $80 billion. Read More

Medicare Funds Drying Up Faster Than Estimated – The Medicare trust fund will be insolvent by 2026, three years earlier than estimates released by the Trump administration last year. That’s partly due to the Tax Cuts and Jobs Act which called for eliminating the individual mandate, according to the 2018 Medicare Trustee Report released Tuesday. Read More

Fierce Health Care: CMS Unveils Medicaid/CHIP ‘Scorecard’ Data – The Trump administration released the inaugural Medicaid and CHIP “scorecard” on June 4, which is intended to reveal how states are performing under the programs. Read More

Modern Health Care: White House Officials Call for ACO Rule Changes – Accountable Care Organizations are failing to meet their promise to save Medicare money, and regulations governing the model need to change, according to senior White House official. Read More

GAO Report: Medicare Needs Better Information to Reduce the Risk of Harm to Beneficiaries – In late May, GAO released a report of Medicare’s efforts to reduce inappropriate opioid prescribing. We suggested ways to help Medicare collect information on doctor investigations and at-risk beneficiaries that could help it determine whether its efforts are working. Read More

GAO Report: CMS Should Take Steps to Mitigate Program Risks in Managed Care – On Wednesday, CMS released a report on Steps to Mitigate Program Risks in Managed Care. Read More

FDA

FDA Takes Action Against 53 Websites Marketing Unapproved Opioids as Part of a Comprehensive Effort to Target Illegal Online Sales – The U.S. Food and Drug Administration announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone. Read More

FDA Approves First Biosimilar to Neulasta to Help Reduce the Risk of Infection During Cancer Treatment – On Monday, the FDA approved Fulphila as the first biosimilar to Neulasta to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia. Read More

Veterans Affairs

USA Today: Trump Signs VA Law to Provide Veterans More Private Health Care Choices – President Trump signed legislation Wednesday paving the way for a major overhaul of the Department of Veterans Affairs and expanded access for veterans to VA-funded care in the private sector. Read More

States

Gov. Northam Signs Virginia Budget, Medicaid Expansion Bill – Governor Ralph Northam signed two bills Thursday that will fund the Commonwealth of Virginia’s government for the rest of Fiscal Year 2018 and all of Fiscal Years 2019 and 2020. Read More

ABC News: Medicaid Work Requirement Bill Sent to Michigan Governor – The Republican-led Michigan Legislature on Thursday gave final approval to a bill requiring able-bodied adults in the state’s Medicaid expansion program to meet work or job-related requirements, sending it to Gov. Rick Snyder for his expected signature. Read More

Washington Post: Trump Administration Won’t Defend ACA in Case Brought by GOP States – The Trump administration said Thursday night that it will not defend the Affordable Care Act against the latest legal challenge to its constitutionality — a dramatic break from the executive branch’s tradition of arguing to uphold existing statutes and a land mine for health insurance changes the ACA brought about. Read More

Primaries

California – Sen. Dianne Feinstein (D-CA) and Lt. Gov Gavin Newsom won early victories. Feinstein will face Democratic State Senator Kevin De Leon and Newsom will face Republican John Cox.

Montana – State auditor and insurance commissioner Matt Rosendale will take on Senator Jon Tester (D-MT) in November.

Iowa – Democrat Pete D’Alessandro will face Rep. David Young (R-IA) in the Iowa 3rd district.

Vox: 5 Winners and 2 Losers From the First Set of this Week’s Primary Elections – June 5 was the biggest primary day of the year — but it may take some time before all the election results are clear. Read More

On June 12, Maine, Nevada, North Dakota, South Carolina and Virginia will head to the polls.

Foley Health Care Law Today

Our attorneys at Foley pride themselves on having a first-hand understanding of health care’s business and legal challenges. Health Care Law Today is your go-to resource for information and perspectives on the latest news and developments in Health care law and how it relates to and impacts the industry and those with related business interests. For some of the blog’s top stories see below:

The VA Mission Act of 2018 and Potential Opportunities for Providers – After a concerted effort, the bipartisan bill to reform the way care is delivered to Veterans has been signed into law. While there are a number of significant reforms, perhaps none are so critical as those related to the ability of Covered Veterans to receive their care outside of the current VA system. Read More

Orthopedics: The New Darling of Private Equity – The past decade has seen a tremendous amount of private equity investment in physician practice recapitalizations, primarily in hospital-based practices such as anesthesiology and radiology as well as “retail medicine practices” like dermatology and ophthalmology/optometry, to name a few. Read More

Looking Ahead

The House and Senate are Both in Session Next Week.

Majority Leader Kevin McCarthy (R-CA) announced in an end-of-week leadership colloquy that the House will vote on several opioid measures next week. The House will consider H.R. 2851 that would establish a new category of synthetic opioids and other drugs under the Controlled Substances Act; H.R. 5735 that would set aside low-income housing vouchers to help people recovering from addiction; and H.R. 5788 that would close loopholes in international shipping to stop the flow of synthetic opioids. First votes are Tuesday at 6:30pm; last votes are no later than 3:00pm.

On Monday, the House Rules Committee will begin setting debate parameters for a synthetic analogue control measure – Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 (H.R. 2851). Read More

On Tuesday, the Senate Judiciary Committee will hold a markup on the combined opioid response package – the Preventing Drug Diversion Act of 2018 (S. 2837). Read More

On Tuesday, the Senate HELP Committee will hold a hearing on Trump’s drug pricing plan. HHS Secretary Alex Azar will testify. Read More

On Tuesday, the Senate Finance Committee will hold a markup on the Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018, which seeks to improve Medicare, Medicaid and human services programs’ response to the opioid crisis. Read More

On Wednesday, the House Veteran Affairs Committee will hold a hearing on six Health care measures and two draft bills. Read More

On June 19, the Senate HELP Committee will hold a hearing on the Effective Administration of the 340B Drug Pricing Program. Read More

Foley & Lardner LLP’s (Foley) Bipartisan Public Policy Team has a proven track record of helping clients achieve their policy priorities at the federal, state and local levels, with extensive experience advocating on behalf of clients involved in various aspects of government engagement. Our team employs a comprehensive approach to government relations. Our work combines high-level policy development, tactical engagement with policymakers, grassroots, business and public relations strategy and targeted lobbying, along with legal representation of an international law firm, when requested by our clients. Our team maintains strong relationships with key Members of Congress, including those in House and Senate Republican and Democratic leadership, and on key committees. The Foley team is your go-to resource in Washington, D.C. for notable Health care developments.